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news.Nuvelo has entered into a special protocol assessment agreement with the FDA for its second pivotal phase III trial of its lead product candidate, alfimeprase, for the treatment of acute peripheral arterial occlusion, or "leg attack."
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The written agreement specifies the terms and conditions under which Nuvelo will conduct and analyze the pivotal phase III trial in support of a regulatory submission.
The trial, known as NAPA-3, is the second of two overlapping multi-national trials for the drug in this indication. The trial will compare alfimeprase to placebo in 300 patients in approximately 100 centers worldwide, with the primary endpoint of avoidance of open vascular surgery within 30 days of randomization.
Previously announced results from the NAPA-1 trial, a phase II dose-escalation study, demonstrated that the drug can restore arterial blood flow within four hours of initiation of dosing, and resulted in a minority of patients requiring open vascular surgery within 30 days of treatment.
“Although the process of securing the special protocol assessment has slightly delayed the start of NAPA-3, we are pleased to have this agreement in place as it solidifies the regulatory pathway to approval for alfimeprase,” said Dr Michael Levy, senior vice president of R&D for Nuvelo.